EUCTR2021-004192-13-FR进行中（未招募）1 期
A Phase II, Multi-center, Open-Label Study to Assess Safety, Tolerability, Efficacy and Pharmacokinetics of R3R01 in Alport Syndrome Patients with Uncontrolled Proteinuria on ACE/ARB Inhibition and in Patients with Primary Steroid-Resistant Focal Segmental Glomerulosclerosis - R3R01 in Alport Syndrome Patients and Primary Steroid-Resistant Focal Segmental Glomerulosclerosis
River 3 Renal, Corporation0 个研究点目标入组 50 人开始时间: 2022年6月9日最近更新:
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 50
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •All Patients:
- •1. Patient is able to communicate well with the investigator, understands
- •and is willing to comply with all requirements of the study, and
- •understands and signs the written informed consent form (ICF).
- •2. For children to be eligible, one or both parents must sign a parental
- •permission form which provides information contained in the ICF.
- •Children capable of assent must express their willingness to
- •participate by signing an assent form.
- •3. Blood pressure in the normotensive or hypertensive range.
- •4. If patient has received a COVID vaccination, the baseline visit must
- •occur at least one week or more after the second/booster vaccination.
- •5. Both female patients, as well as, female partners of male patients who
- •are of child-bearing potential must be willing to not become pregnant
- •for the complete duration of the study (>180 days) (90 days after the
- •last dose of study medication).
- •AS Inclusion Criteria (in addition):
- •6. Male and female patients from age 12 years and older, males and
- •females with X-Linked AS and males and females with autosomal
- •recessive AS.
- •7. Confirmed diagnosis of AS by genetic testing and /or kidney biopsy.
- •8. UPCR =1.0 g/g.
- •9. eGFR = 45 mL/min/1.73m2.
- •10. ACEi/ARB therapy at maximum tolerated dose stable for at least 4
- •weeks prior to screening. ACEi/ARB dose should remain stable over
- •the course of the study.
- •FSGS Inclusion Criteria (in addition):
- •11. Male or female patients, 12 to 75 years old at the time of signing the
- •informed consent.
- •12. Primary FSGS, i.e. without any identifiable cause, and confirmed by
- •renal biopsy or documentation of a genetic mutation in a podocyte
- •protein associated with FSGS.
- •13. Steroid-resistance defined as failure to achieve partial or complete
- •remission, or experienced adverse events without acceptable clinical
- •benefit after at least 8 weeks of adequate corticosteroid therapy for
- •children and 12 weeks for adults.
- •14. UPCR between 3.5g/g and 12.0g/g.
- •15. eGFR > 45 mL/min/1.73m2.
- •16. If taking concomitant ACE and/or ARB treatment, it should remain
- •at a stable dose for a minimum of 28 days prior to enrollment and
- •during the course of the study.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 15
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 32
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 3
排除标准
- •All Patients:
- •1. Uncontrolled diabetes mellitus as evidenced by an HbA1c = 11%.
- •2. Uncontrolled hypertension
- •a. Adults: (SBP = 180mmHg and/or DBP = 100mmHg).
- •b. Children: = 95th percentile or = 130/80 mm Hg, whichever is
- •lower, as defined in Appendix 13.8.
- •3. Moderate or severe hepatic impairment as per Child Pugh score (See
- •Section 9.5.4.6)
- •4. Presence of any active (i.e., with symptoms) and/or uncontrolled
- •infection (including COVID).
- •5. Human immunodeficiency virus (HIV).
- •6. BMI > 40.
- •7. History of malignancy other than treated basal cell or squamous cell
- •skin cancer within the past 5 years.
- •8. History of alcohol abuse in the last 5 years or currently drinks in excess
- •of 21 and 14 units per week for males and females, respectively.
- •9. Received an investigational agent within 30 days or 5 half-lives prior
- •to screening (whichever is longer).
- •10. History of non-compliance such that patient is unlikely to be compliant
- •with study visits, procedures or drug administration.
- •11. Patient has had an organ transplant, is currently on an organ transplant
- •waiting list or there is a reasonable possibility that the patient will have
- •an organ transplant in the 6 months after screening.
- •12. Participation in an interventional trial within the previous 3 months
- •prior to screening or concurrent participation in a research trial.
- •13. Patient is not suitable to participate in the study for any reason
- •(including, but not limited to co-morbidities, history of noncompliance
- •with study visits, procedures, or drug administration) in the
- •opinion of the investigator.
- •14. Females of childbearing potential (those who are not surgically
- •sterilized or post-menopausal for at least 1 year) are excluded from
- •participation in the study unless they agree to use adequate
- •contraception as described in Section 13.3.
- •15. Males who have no sterilization history and whose female partners
- •have child-bearing potential, must agree to use highly effective method
- •of contraception during the period from the time of signing the
- •informed consent form (ICF) through 90 days after the last dose of study drug. They must agree to immediately inform the investigator if
- •their partner becomes pregnant during the study.
- •AS Exclusion Criteria (in addition):
- •16. Kidney disease apart from AS, e.g. diabetic nephropathy or lupus
- •17. Bardoxolone treatment in the 90 days prior to screening.
- •FSGS Exclusion Criteria (in addition):
- •18. Patient has collapsing variant of FSGS on renal biopsy.
- •19. Patient has FSGS secondary to another condition (e.g. obesity,
- •cardiovascular, infectious, or autoimmune disorder).
- •20. Rituximab, cyclophosphamide or abatacept treatment in the 120 days
- •prior to screening. If taking other chronic immuno-modulatory
- •medications that are small molecules, the dosage must be stable for 4
- •weeks prior to screening.
- •21. If previous Rituximab treatment is greater than 120 days from
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